Panacea Biotec reaches settlement with Apotex
Apotex will also pay US$ 2.5 million upon receipt of final USFDA approval of the ANDA that is the subject of the Collaboration Agreement for Paclitaxel Protein-Bound Particles for Injectable Suspension
Apotex will also pay US$ 2.5 million upon receipt of final USFDA approval of the ANDA that is the subject of the Collaboration Agreement for Paclitaxel Protein-Bound Particles for Injectable Suspension
Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility
Xtandi is approved in over 80 countries, including the U.S., EU, and Japan
The submission is based on data from the STEP UP and STEP UP T2D clinical trials
He has held senior leadership positions at Syngene International, Fujifilm Diosynth Biotechnologies, Thermo Fisher Scientific, Sartorius Stedim Biotech, and other leading organizations
Commercial production is expected to begin soon
Approval based on NIAGARA Phase III trial results which showed a 32% reduction in the risk of recurrence and a 25% reduction in the risk of death for the Imfinzi regimen vs. neoadjuvant chemotherapy alone
atai and Beckley Psytech plan to meet with the U.S. Food and Drug Administration (FDA) and other regulatory agencies to finalize the Phase 3 trial design.
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